Traditional Drug Pipeline Monthly Update: August 2023

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Ycanth^® (cantharidin): The U.S. Food and Drug Administration (FDA) has approved Verrica Pharmaceuticals’ Ycanth for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients 2 years of age and older. Ycanth is a drug-device combination product applied by a health care professional that delivers cantharidin, a blistering agent, in purple liquid via a single-use applicator. The coloring is meant to clearly mark treated lesions. Ycanth was approved based on the Phase 3 CAMP-1 and CAMP-2 trials where patients received either Ycanth or placebo applied once to all affected lesions every 21 days for up to four applications. In CAMP-1, almost 50% in the Ycanth group achieved the primary endpoint compared to 18% in the placebo group (p<0.0001). In CAMP-2, 54% of treated patients Ycanth group and 13% in the placebo group met the primary endpoint (p<0.0001). The most common adverse reactions reported with Ycanth were local skin reactions at the application site.¹ Ycanth is expected to be available by September 2023 with pricing to follow. Compounded cantharidin has been used in the past to treat molluscum.
• Xdemvy^®(lotilaner ophthalmic solution) 0.25%: The FDA approved Tarsus Pharmaceuticals’ Xdemvy for the treatment of Demodex blepharitis, eyelid inflammation caused by Demodex mites. Xdemvy is dosed as a single drop in each eye twice daily for 6 weeks. Xdemvy was approved based on Phase 3 trials, SATURN-1 and SATURN-2, which demonstrated a significant improvement in eyelids (reduction of collarettes which indicates the presence of mites) compared to placebo.² Xdemvy will have a list price of $1,850 per one time prescription and will be available at the end of August 2023.
• RiVive^® (naloxone 3mg nasal spray): The FDA has approved Harm Reduction Therapeutics’ RiVive, an over-the-counter (OTC) emergency treatment of opioid overdose. RiVive was approved via the 505(b)2 pathway using Emergent’s Narcan^®(naloxone) as its reference product. RiVive is expected to launch in early 2024. Harm Reduction Therapeutics noted it costs $36 to manufacturer and package each twin pack and that price will allow them to give 10% of their inventory away for free (~100,000 twin packs in Year 1).³
• Balfaxar^®(prothrombin complex concentrate, human-lans): The FDA has approved Octapharma’s Balfaxar^® for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. The FDA approval is supported by the Phase 3 clinical trial LEX-209, which compared the efficacy and safety of Balfaxar head-to-head with CSL Behring’s Kcentra^® (Prothrombin Complex Concentration, Human) Balfaxar was found to be non-inferior to Kcentra in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk by demonstrating an effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra.⁴ The safety profile was similar between treatment arms.⁴ Launch and price of Balfaxar are pending.
• Zurzuvae^® (zuranolone): Sage Therapeutics’ Zurzuvae was approved by the FDA for adults with postpartum depression (PPD). Zurzuvae is the first oral, once-daily, 14-day treatment for women with PPD. This approval was based on results from two Phase 3 trials, ROBIN and SKYLARK, both of which met their primary endpoint of a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression total score at Day 15 compared to placebo. Zurzuvae is expected to launch in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration. Pricing has not been announced. The FDA issued a Complete Response Letter (CRL) for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage and Biogen are reviewing the feedback and evaluating next steps.⁵

Generic Drug Information

• Mozobil^® (plerixafor inj, 24mg/1.2 mL): Multiple manufacturers have launched their generic version of Sanofi Pharmaceuticals’ Mozobil, a hematopoietic stem cell mobilizer, indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. Mozobil generated $202 million in U.S. annual sales in 2022.
• Symbicort^® (Breyna™, budesonide-formoterol fumarate dihyd aerosol 80-4.5 mcg/act, 160-4.5 mcg/act): Mylan/Kindeva has launched their generic version of AstraZeneca’s Symbicort for the treatment of asthma in patients 6 years of age and older and for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Teva may launch their generic version later this year or into 2024. Symbicort generated $3.848 billion in U.S. annual sales in 2022.
• Onglyza^® (saxagliptin tab, 2.5mg, 5mg): Multiple manufacturers have launched their generic versions of BMS/AstraZeneca’s Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. Onglyza generated $134 million in U.S. annual sales in 2022.
• Kombiglyze XR (saxagliptin-metformin, tab ER 24hr, 2.5-1000mg, 5-500mg, 5-1000mg): Dr. Reddy’s and Mylan launched their generic versions of BMS/AstraZeneca’s Kombiglyze XR as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Multiple manufacturers are set to launch their versions this year. Kombiglyze XR generated $55 million in U.S. annual sales in 2022.
• Spiriva Handihaler (tiotropium inhal cap, 18 mcg): Lupin launched their generic version of BI’s Spiriva Handihaler for the treatment of chronic obstructive pulmonary disease (COPD). No other generic versions are set to launch in 2023. Spiriva Handihaler generated $1,526 million in U.S. annual sales in 2022.
• Trionex (calcipotriene cream dressing kit, 0.005%): Forreal Pharmaceuticals launched their generic version of V2 Pharma’s Trionex for the treatment of plaque psoriasis.
• Balcoltra [levonorgestrel-ethinyl estradiol-fe tab, 0.1mg-20 mcg (21)]: Xiromed launched their generic version of Avion’s Balcoltra for pregnancy prevention. Lupin’s generic version is set to launch in 2024. Balcoltra generated $50 million in U.S. annual sales in 2022.

New Indications

• None

References

1. https://www.empr.com/home/news/ycanth-a-drug-device-combo-for-molluscum-contagiosum-gets-approval/
2. https://ir.tarsusrx.com/static-files/dd3cb072-0e9d-4657-b6aa-e3f3435049c6
3. https://www.formularywatch.com/view/fda-approves-second-over-the-counter-naloxone-nasal-spray
4. https://www.prnewswire.com/news-releases/octapharmas-prothrombin-complex-concentrate-balfaxar-receives-fda-approval-for-warfarin-reversal-in-urgent-surgery–invasive-procedures-301886222.html
5. https://investors.biogen.com/news-releases/news-release-details/fda-approves-zurzuvaetm-zuranolone-first-and-only-oral-treatment